Senior Director, Clinical Pharmacology & Strategy

Otsuka America Pharmaceutical Inc.; Carson City (NV); On-site; USD 231,000 - 345,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Clinical Pharmacology Lead to guide pharmacology strategy across all stages of drug development.

The role involves overseeing PK/PD modeling, dose selection, and regulatory submissions, while mentoring junior scientists within the Quantitative Pharmacology team. You will work closely with pharmacometrics, biomarkers, and clinical development to optimize study designs and ensure alignment with program goals.

Qualifications

• Extensive experience developing and executing clinical pharmacology strategies for multiple programs across all phases.
• In-depth knowledge of early phase study design, PK/PD, biomarker, and bioanalytical assays.
• Hands-on PK/PD data analysis and modeling with standard tools.

Responsibilities

• Lead development of clinical pharmacology sections for regulatory filings (INDs/NDAs/BLAs).
• Support model-based drug development strategies and PK/PD analyses for dose selection and safety assessment.
• Oversee cross-functional pharmacology studies and collaborations with translational science teams.
• Mentor and develop junior scientists within the Quantitative Pharmacology group.

Skills

Clinical pharmacology leadership

PK/PD analysis

Regulatory filings

Cross-functional collaboration

Project mentorship

Education

PhD in Clinical Pharmacology

Tools

Phoenix NLME

Model-based drug development

Job description

Otsuka America Pharmaceutical Inc. is seeking a Clinical Pharmacology Lead to guide pharmacology strategy across all stages of drug development.

The role involves overseeing PK/PD modeling, dose selection, and regulatory submissions, while mentoring junior scientists within the Quantitative Pharmacology team. You will work closely with pharmacometrics, biomarkers, and clinical development to optimize study designs and ensure alignment with program goals.